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Completed

NCT Number: NCT04067869

Cytomegalovirus Infection in Patients With HIV-1 Infection

The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomegalovirus infection and auto-immune disorders.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bordeaux, France

About this study

T cell activation plays a central role in HIV pathogenesis and is highly correlated to disease progression even in HIV patients virosuppressed on combined antiretroviral therapy since years. The mechanisms underlying this activation in virosuppressed patients are poorly understood. Identifying some factors involved in immune activation that can be targeted by therapies could optimize the treatment of HIV patients. The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomégalovirus infection and auto-immune disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients included in the Aquitaine ANRS CO3 cohort aged 18 years or older (confirmed HIV-1 infection and at least one follow-up in the cohort),
  • plasma HIV-1 RNA <50 copies / ml for at least 24 months under a highly active antiretroviral combination (treatment comprising at least 3 antiretroviral drugs) modified or initiated between 2005 and 2008,
  • Follow-up in one of the departments of Bordeaux University Hospital or Libourne Hospital,
  • Free, informed and written consent, signed by the patient and the investigator (Consent of the Aquitaine CO3 Cohort and linked to this specific study).

Exclusion criteria

  • Presence of 2 consecutive measurements of HIV RNA> 50 copies / ml,
  • History of immunotherapy treatments (interleukin-2),
  • Hepatitis B or C co-infections,
  • Pregnancy
  • Breastfeeding
  • Symptomatic infectious episode in progress.

Treatment and study plan

Blood samples

Procedure

Blood sample containing 3 ethylene-diamine-tetra-acetic acid tubes (7ml), 3 dry tubes (7ml) and 5 citrated tubes, ie 9 tubes

Primary outcomes

  1. Measurement of systemic lymphocyte activation

    Time frame: At the screening

    Measured by the expression of HLA-DR and CD38 markers on the surface of CD4 + and CD8 + LT by flow cytometry

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Participation of Cytomegalovirus Infection or an Autoimmune Process in T Lymphocyte Activation of HIV-1 Infected Patients With Undetectable Viral Load on Antiretroviral Therapy.

Acronym: ACTHIV

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 28, 2019
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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